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Effects of Atorvastatin on Blood Pressure and Urinary Albumin Excretion

Primary Purpose

Hypertension, Hypercholesterolemia

Status
Completed
Phase
Not Applicable
Locations
Greece
Study Type
Interventional
Intervention
Atorvastatin
Placebo
Sponsored by
Aristotle University Of Thessaloniki
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Hypertension focused on measuring essential hypertension

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • LDL-C>130 or >160 mg/dL (depending on the total risk according to the most recent recommendations25).
  • no previous hypolipidemic medication
  • ability to provide Informed Consent.

Exclusion Criteria:

  • pregnancy or lactation
  • myocardial infarction or unstable angina within the past 6 months
  • heart failure NYHA class III-IV
  • renal disease (SCr>3 mg/dL or proteinuria>3g/d)
  • liver disease
  • history of malignancy
  • history of drug or alcohol abuse
  • treatment with corticosteroids
  • any other condition with poor prognosis
  • inability to provide Informed Consent.

Sites / Locations

  • AHEPA University Hospital of Thessaloniki

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Atorvastatin

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Ambulatory blood pressure

Secondary Outcome Measures

Urinary Albumin Excretion
Insulin Sensitivity
Arterial Stiffness
Urinary levels of nephrin
Urinary levels of podocalyxin
Urinary levels of Endothelin-1
Urinary levels of Asymmetric Dimethylarginine
Urinary levels of indices of oxidative stress

Full Information

First Posted
May 19, 2010
Last Updated
May 19, 2010
Sponsor
Aristotle University Of Thessaloniki
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1. Study Identification

Unique Protocol Identification Number
NCT01126684
Brief Title
Effects of Atorvastatin on Blood Pressure and Urinary Albumin Excretion
Official Title
EFFECTS OF ATORVASTATIN ON BLOOD PRESSURE AND URINARY ALBUMIN EXCRETION IN PATIENTS WITH ESSENTIAL HYPERTENSION
Study Type
Interventional

2. Study Status

Record Verification Date
April 2010
Overall Recruitment Status
Completed
Study Start Date
June 2008 (undefined)
Primary Completion Date
December 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Aristotle University Of Thessaloniki

4. Oversight

5. Study Description

Brief Summary
To evaluate the possible effects of atorvastatin on ambulatory blood pressure, urinary albumin excretion, insulin resistance and arterial stiffness in hypertensive patients, beyond those on lipid profile. Glycemic parameters, "novel" cardiovascular risk factors and safety parameters will be also evaluated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypertension, Hypercholesterolemia
Keywords
essential hypertension

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Atorvastatin
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Atorvastatin
Intervention Description
10 mg of atorvastatin once daily for six months
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
placebo once daily for six months
Primary Outcome Measure Information:
Title
Ambulatory blood pressure
Time Frame
Six months
Secondary Outcome Measure Information:
Title
Urinary Albumin Excretion
Time Frame
Six months
Title
Insulin Sensitivity
Time Frame
Six months
Title
Arterial Stiffness
Time Frame
Six months
Title
Urinary levels of nephrin
Time Frame
Six months
Title
Urinary levels of podocalyxin
Time Frame
Six months
Title
Urinary levels of Endothelin-1
Time Frame
Six months
Title
Urinary levels of Asymmetric Dimethylarginine
Time Frame
Six months
Title
Urinary levels of indices of oxidative stress
Time Frame
Six months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: LDL-C>130 or >160 mg/dL (depending on the total risk according to the most recent recommendations25). no previous hypolipidemic medication ability to provide Informed Consent. Exclusion Criteria: pregnancy or lactation myocardial infarction or unstable angina within the past 6 months heart failure NYHA class III-IV renal disease (SCr>3 mg/dL or proteinuria>3g/d) liver disease history of malignancy history of drug or alcohol abuse treatment with corticosteroids any other condition with poor prognosis inability to provide Informed Consent.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Anastasios Lasaridis, MD, PhD
Organizational Affiliation
Aristotle University Of Thessaloniki
Official's Role
Principal Investigator
Facility Information:
Facility Name
AHEPA University Hospital of Thessaloniki
City
Thessaloniki
ZIP/Postal Code
54636
Country
Greece

12. IPD Sharing Statement

Citations:
PubMed Identifier
23449607
Citation
Kanaki AI, Sarafidis PA, Georgianos PI, Kanavos K, Tziolas IM, Zebekakis PE, Lasaridis AN. Effects of low-dose atorvastatin on arterial stiffness and central aortic pressure augmentation in patients with hypertension and hypercholesterolemia. Am J Hypertens. 2013 May;26(5):608-16. doi: 10.1093/ajh/hps098. Epub 2013 Feb 28.
Results Reference
derived

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Effects of Atorvastatin on Blood Pressure and Urinary Albumin Excretion

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